Skip to content

Phasor Gre.dri

by Phasor Health, LLC

Phasor Gre.dri is a Class II device made by Phasor Health, LLC, cleared under FDA 510(k) K252060 on 31 Oct 2025 and listed in FDA GUDID since 24 Nov 2025 (UDI-DI B775GREDRI0), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K252060

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB775GREDRI0 UDI-DI Date24 Nov 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK252060 Date31 Oct 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K252060 decided 31 Oct 2025 Active
  • FDA GUDID UDI-DI B775GREDRI0 listed 24 Nov 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K252060
  2. Listed FDA GUDID B775GREDRI0

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Phasor
Generic name
Cranial trephine, single-use
Model / reference
GRE.DRI
Primary DI / UDI-DI
B775GREDRI0
510(k) Number
FDA product code
HBE
GMDN term
Cranial trephine, single-use
Device class
Class II
Regulation number
882.4310
GUDID distribution status
In Commercial Distribution
Sterilisation method
Hydrogen Peroxide
MRI safety
MR Unsafe

Related devices

Cleared under the same submission (K252060)

Other devices from Phasor Health, LLC

  • Phasor 11.0l Open recall

    Class II

  • Phasor 11.0S Open recall

    Class II

  • Phasor 14.0S Open recall

    Class II

  • Phasor 14.0l Open recall

    Class II

See all devices from Phasor Health, LLC →

Properties

  • Sterilise before use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)